TW201818993A - System for wirelessly coupling in vivo - Google Patents

System for wirelessly coupling in vivo Download PDF

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Publication number
TW201818993A
TW201818993A TW106138162A TW106138162A TW201818993A TW 201818993 A TW201818993 A TW 201818993A TW 106138162 A TW106138162 A TW 106138162A TW 106138162 A TW106138162 A TW 106138162A TW 201818993 A TW201818993 A TW 201818993A
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stimulation device
electrodes
stimulation
implantable
item
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TW106138162A
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Chinese (zh)
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里茲萬 巴西如拉
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英商加爾維尼生物電子有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B5/00Near-field transmission systems, e.g. inductive or capacitive transmission systems
    • H04B5/20Near-field transmission systems, e.g. inductive or capacitive transmission systems characterised by the transmission technique; characterised by the transmission medium
    • H04B5/24Inductive coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • A61N1/0556Cuff electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37217Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223Circuits for electromagnetic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3752Details of casing-lead connections
    • A61N1/3754Feedthroughs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3756Casings with electrodes thereon, e.g. leadless stimulators
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04BTRANSMISSION
    • H04B5/00Near-field transmission systems, e.g. inductive or capacitive transmission systems
    • H04B5/20Near-field transmission systems, e.g. inductive or capacitive transmission systems characterised by the transmission technique; characterised by the transmission medium
    • H04B5/24Inductive coupling
    • H04B5/26Inductive coupling using coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0204Operational features of power management
    • A61B2560/0214Operational features of power management of power generation or supply
    • A61B2560/0219Operational features of power management of power generation or supply of externally powered implanted units
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3507Communication with implanted devices, e.g. external control
    • A61M2205/3538Communication with implanted devices, e.g. external control using electrical conduction through the body of the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Signal Processing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Electromagnetism (AREA)
  • Acoustics & Sound (AREA)
  • Electrotherapy Devices (AREA)
  • Power Engineering (AREA)

Abstract

Implantable systems are described that include a stimulation device positionable in vivo and configured to communicatively couple to electrodes configured to stimulate or block body tissue and an auxiliary device positionable in vivo and including one or more coils configured to wirelessly couple, in vivo, to the stimulation device and to wirelessly couple to an ex vivo device. The auxiliary device may include a coil driver and a power source controlled by a processor and memory for storing data instructions for the coil driver and for storing data received from the stimulation device. The auxiliary device may also include a radio transceiver and an antenna. The stimulation device may include a housing, a coil, a power source and an integrated circuit for controlling the electrodes. The stimulation device may be coupled to a cuff via a lead and physically coupled to the auxiliary device.

Description

用於體內的無線耦合系統    Wireless coupling system for the body   

與其他申請案之交互引用 Cross-references with other applications

本申請案要求2016年11月4日提交的美國臨時申請案62/417,423的優先權,其名稱為「用於體內的無線耦合系統」,該臨時申請案之公開內容藉由引用而納為本文揭露之一部分。 This application claims priority from US Provisional Application 62 / 417,423, filed November 4, 2016, entitled "Wireless Coupling System for the Body", the disclosure of which is incorporated herein by reference. Exposing part.

本揭露內容是有關於體內可植入裝置,且更特別是(雖然不一定僅限於)用於在體內裝置之間進行無線耦合的系統。 This disclosure relates to implantable devices in vivo, and more particularly (though not necessarily limited to) systems for wireless coupling between in vivo devices.

一種體內可植入裝置可被耦接至或包含一具有多個電極的引線,此些電極被安置以接觸身體組織。此些電極可感測關於身體組織、源電流或灌電流(sink current)之資訊以導致身體組織的一電性改變,這可導致在身體組織中傳播的生理信號的阻斷或刺激,或者執行這些或其他功能的組合。此些電極可經由多條配線被通訊地耦接至可植入裝置之一連接器,用以傳輸資料及電能或磁能。每個電極可被通訊地耦接至一在連接器上之接點。 An in vivo implantable device may be coupled to or include a lead having a plurality of electrodes that are positioned to contact body tissue. These electrodes can sense information about body tissue, source current, or sink current to cause an electrical change in the body tissue, which can lead to the blocking or stimulation of physiological signals transmitted in the body tissue, or perform A combination of these or other features. These electrodes can be communicatively coupled to a connector of the implantable device via a plurality of wires for transmitting data and electrical or magnetic energy. Each electrode can be communicatively coupled to a contact on the connector.

供身體組織用之更多電極可導致更好的解析度,以提高對記錄和刺激能力和選擇的選擇性。然而,由於可植入裝置上的尺寸限制,限制了供身體組織用之電極之數目,而限制了可以實體上包含在可植入裝置 中供此些電極用之連接器接點之數目。 More electrodes for body tissue can lead to better resolution to increase selectivity for recording and stimulation capabilities and selection. However, due to size limitations on implantable devices, the number of electrodes for body tissue is limited, and the number of connector contacts that can be physically contained in an implantable device for such electrodes is limited.

本發明揭露一種可植入系統,包含一刺激裝置及一輔助裝置。其中,刺激裝置可在體內定位並配置成通訊地耦接至多個電極,這些電極配置成刺激或阻斷身體組織。輔助裝置可在體內定位並包含一個或多個線圈,配置成在體內無線地耦接至刺激裝置及無線地耦接至一體外裝置。 The invention discloses an implantable system including a stimulation device and an auxiliary device. The stimulation device may be positioned in the body and configured to be communicatively coupled to a plurality of electrodes, and the electrodes are configured to stimulate or block body tissue. The assistive device can be positioned in the body and includes one or more coils configured to be wirelessly coupled to the stimulation device in vivo and to an external device wirelessly.

本發明揭露一種可植入裝置,包含一積體電路及一個或多個線圈。積體電路配置成通過一介面管理到達配置成刺激或阻斷身體組織之多個電極的信號傳輸。一個或多個線圈的配置成在體內無線地耦接至定位於體內之一輔助裝置並配置成無線地耦接至一體外裝置。 The invention discloses an implantable device including an integrated circuit and one or more coils. The integrated circuit is configured to manage signal transmission to multiple electrodes configured to stimulate or block body tissue through an interface. The one or more coils are configured to be wirelessly coupled in vivo to an auxiliary device positioned in the body and configured to be wirelessly coupled to an extracorporeal device.

本發明揭露一種可植入系統,包含一刺激裝置及一輔助裝置。刺激裝置可在體內定位並配置成用於執行可植入系統之兩個子集之功能之一第一子集以監視、刺激或阻斷身體組織。輔助裝置可在體內定位並配置成用於執行可植入系統之兩個子集之功能之一第二子集以監視、刺激、阻斷身體組織,輔助裝置包含一個或多個線圈,配置成在體內無線地耦接至刺激裝置並配置成無線地耦接一體外裝置。 The invention discloses an implantable system including a stimulation device and an auxiliary device. The stimulation device may be positioned in vivo and configured to perform a first subset of the functions of two subsets of the implantable system to monitor, stimulate or block body tissue. The assistive device can be positioned in the body and configured to perform one of the two subsets of the functions of the implantable system. A second subset is used to monitor, stimulate, and block body tissue. The assistive device includes one or more coils configured to Wirelessly coupled to the stimulation device in vivo and configured to wirelessly couple to an external device.

10‧‧‧系統 10‧‧‧System

12‧‧‧輔助裝置 12‧‧‧ auxiliary device

14‧‧‧刺激裝置 14‧‧‧ Stimulator

16‧‧‧電極 16‧‧‧ electrode

18‧‧‧體內側 18‧‧‧ inside the body

20‧‧‧身體組織 20‧‧‧ Body tissue

22‧‧‧體外裝置 22‧‧‧ Extracorporeal device

24‧‧‧體外側 24‧‧‧ outside the body

26、28、30‧‧‧線圈 26, 28, 30‧‧‧ coils

32、34‧‧‧天線 32, 34‧‧‧ antenna

100‧‧‧輔助裝置 100‧‧‧ auxiliary device

102‧‧‧刺激裝置 102‧‧‧stimulation device

106‧‧‧無線電收發器 106‧‧‧Radio Transceiver

108‧‧‧天線 108‧‧‧ Antenna

110‧‧‧記憶體 110‧‧‧Memory

112‧‧‧線圈驅動器 112‧‧‧coil driver

114‧‧‧電池 114‧‧‧ Battery

116‧‧‧線圈 116‧‧‧coil

118‧‧‧積體電路 118‧‧‧Integrated Circuit

120‧‧‧線圈 120‧‧‧coil

122‧‧‧電極介面 122‧‧‧ electrode interface

124‧‧‧鄰近鏈路 124‧‧‧adjacent link

126‧‧‧電池/電源 126‧‧‧Battery / Power

200‧‧‧輔助裝置 200‧‧‧ auxiliary device

202‧‧‧射頻收發器 202‧‧‧RF Transceiver

204‧‧‧天線 204‧‧‧ Antenna

206‧‧‧記憶體 206‧‧‧Memory

208‧‧‧線圈 208‧‧‧coil

210‧‧‧電源 210‧‧‧ Power

212‧‧‧積體電路 212‧‧‧Integrated Circuit

214‧‧‧電極 214‧‧‧electrode

300‧‧‧刺激裝置 300‧‧‧ Stimulator

302‧‧‧外殼 302‧‧‧shell

304‧‧‧線圈 304‧‧‧coil

306‧‧‧電池/電源 306‧‧‧Battery / Power

308‧‧‧積體電路 308‧‧‧Integrated Circuit

310‧‧‧饋通 310‧‧‧Feedthrough

400‧‧‧引線 400‧‧‧ Lead

402‧‧‧壓脈帶 402‧‧‧pressure vein belt

500‧‧‧輔助裝置 500‧‧‧ auxiliary device

502‧‧‧頭部 502‧‧‧Head

600‧‧‧線圈 600‧‧‧coil

602‧‧‧線圈 602‧‧‧coil

700‧‧‧刺激裝置 700‧‧‧ Stimulator

702‧‧‧壓脈帶 702‧‧‧pressure vein belt

704‧‧‧頂端部分 704‧‧‧Top

800‧‧‧接觸介面 800‧‧‧Contact interface

801‧‧‧接點 801‧‧‧Contact

802‧‧‧傳導線 802‧‧‧ Conductive wire

900‧‧‧接觸介面 900‧‧‧ contact interface

902‧‧‧引線配線 902‧‧‧lead wiring

904‧‧‧焊球 904‧‧‧solder ball

圖1為依據一個例子之一種具有可無線地耦接體內之多個部件的系統的方塊圖。 FIG. 1 is a block diagram of a system having a plurality of components in a body that can be wirelessly coupled according to an example.

圖2為依據一個例子之一可植入系統之一輔助裝置及一刺激裝置之方塊圖。 FIG. 2 is a block diagram of an auxiliary device and a stimulation device of an implantable system according to an example.

圖3為依據另一個例子之一輔助裝置之方塊圖。 FIG. 3 is a block diagram of an auxiliary device according to another example.

圖4A為依據一個例子之一刺激裝置之透視圖。 FIG. 4A is a perspective view of a stimulation device according to an example.

圖4B為依據一個例子之刺激裝置之前視圖。 FIG. 4B is a front view of the stimulation device according to an example.

圖5說明依據一個例子之經由一引線耦接至一包含多個電極之壓脈帶(cuff)之刺激裝置之一例。 FIG. 5 illustrates an example of a stimulation device coupled to a cuff comprising a plurality of electrodes via a lead according to an example.

圖6為依據一個例子之實體上容納在一輔助裝置之一部分中之圖5之刺激裝置之透視圖。 FIG. 6 is a perspective view of the stimulation device of FIG. 5 physically contained in a part of an auxiliary device according to an example.

圖7為依據一個例子之來自圖6之刺激裝置與輔助裝置之側視圖。 FIG. 7 is a side view of the stimulation device and the auxiliary device from FIG. 6 according to an example.

圖8A為依據一個例子之一刺激裝置及一壓脈帶之透視圖。 FIG. 8A is a perspective view of a stimulation device and a blood pressure band according to an example.

圖8B為依據一個例子之圖8A之刺激裝置與壓脈帶之側視圖。 FIG. 8B is a side view of the stimulation device and the pressure cuff of FIG. 8A according to an example.

圖9說明依據一個例子之供一刺激裝置用之一接觸介面之局部俯視圖。 Figure 9 illustrates a partial top view of a contact interface for a stimulation device according to an example.

圖10說明依據一個例子之耦接至另一個部件之一接觸介面之側視圖。 FIG. 10 illustrates a side view of a contact interface coupled to another component according to an example.

某些實施樣態及特徵是關於體內裝置之間的無線耦合。一個體內刺激裝置可包含一線圈,其經由電磁感應可以與一個體內輔助裝置之一線圈通信。藉由體內裝置之間的無線耦合,部件及功能可以在一個以上的裝置之間被分割,且刺激裝置可具有更多空間以與更多的用於身體組織的電極接合,而不增加尺寸。舉例而言,刺激裝置可輸出多個信號給多個電極,以刺激或阻斷身體組織,並接收關於被此些電極所偵測到的身體組織之資料。 Some implementation aspects and features are related to wireless coupling between in-vivo devices. An in vivo stimulation device may include a coil that communicates with one of the coils of an in vivo assistive device via electromagnetic induction. With wireless coupling between in-vivo devices, components and functions can be split between more than one device, and the stimulation device can have more space to engage more electrodes for body tissue without increasing size. For example, the stimulation device may output multiple signals to multiple electrodes to stimulate or block body tissue, and receive information about the body tissue detected by the electrodes.

多個用以刺激或阻斷身體組織之輸出信號和從身體組織的 紀錄之組合可以以同步、即時和一閉迴路的方式被完成,用以達到改善的治療功效。再者,經由電極到達源電流或灌電流的刺激可導致身體組織的一電性改變,這可導致在身體組織中傳播的生理信號的阻斷或刺激。身體組織之例子包含神經組織(譬如中樞神經系統之神經、周邊神經系統之神經、自主神經、軀體神經、交感神經、副交感神經、脊神經、顱神經、胸神經、腰部神經、骶神經、顱神經、運動神經及感覺神經)、結締組織(譬如骨頭、纖維結締組織或血管,其可能是靜脈、動脈或微血管)、上皮組織及肌肉組織(其可包含肌肉纖維)。身體組織此用語係意圖包含器官,其可能包含一個或多個組織型式。因此,經由電極刺激可導致信號阻斷或信號刺激(例如激發),例如那些在神經和纖維中傳播的神經信號。輔助裝置可提供多個命令給刺激裝置,以控制此些信號之時序與頻率以及資料獲取功能,且其亦可具有一較大電源,用以提供電力給刺激裝置,而不需要患者參與。 The combination of multiple output signals to stimulate or block body tissue and records from body tissue can be accomplished in a synchronized, instant, and closed-loop manner to achieve improved therapeutic efficacy. Furthermore, the stimulation of the source current or the sink current via the electrodes can cause an electrical change in the body tissue, which can lead to the blocking or stimulation of the physiological signals transmitted in the body tissue. Examples of body tissue include neural tissue (such as nerves of the central nervous system, nerves of the peripheral nervous system, autonomic nerves, somatic nerves, sympathetic nerves, parasympathetic nerves, spinal nerves, cranial nerves, thoracic nerves, lumbar nerves, sacral nerves, cranial nerves, Motor and sensory nerves), connective tissue (such as bones, fibrous connective tissue or blood vessels, which may be veins, arteries or microvessels), epithelial tissue and muscle tissue (which may include muscle fibers). The term body tissue is intended to include organs, which may include one or more tissue types. Thus, stimulation via electrodes can lead to signal blocking or signal stimulation (e.g., excitation), such as those of neural signals that propagate in nerves and fibers. The auxiliary device can provide multiple commands to the stimulation device to control the timing and frequency of these signals and data acquisition functions, and it can also have a larger power supply to provide power to the stimulation device without the need for patient participation.

在某些例子中,可從身體移除輔助裝置,而刺激裝置可留在身體內。接著可植入一個具有額外功能之新的輔助裝置,而不需要破壞與刺激裝置耦接的電極附近的身體組織。新的輔助裝置可以以無線方式輸出命令及電力至刺激裝置。在其他例子中,可移除(或不植入)輔助裝置,而刺激裝置可與一體外裝置(可能是一可穿戴裝置)無線地耦接。 In some examples, the assistive device may be removed from the body and the stimulation device may remain in the body. A new assist device with additional functions can then be implanted without destroying the body tissue near the electrodes coupled to the stimulation device. The new auxiliary device can output commands and power to the stimulation device wirelessly. In other examples, the assistive device may be removed (or not implanted), and the stimulation device may be wirelessly coupled with an external device (possibly a wearable device).

刺激裝置可以是一種供神經調節系統用之植入醫療裝置(Implant Medical Device,IMD)架構之一部分,其中一積體電路位於一近端處的一外殼中,而多個電極(或身體組織接點)位於遠端,且依據體內目標介入點被配置成一壓脈帶或其他形狀,或包含在一引線上。與傳統的植入醫療裝置比較而言,刺激裝置可以是相對小的,而某些例子之一剖面尺寸係與 一引線之一剖面尺寸相同或類似。一刺激裝置可以被密封地納入在一具有多個電請通(electrical feedthrough)之生物相容性陶瓷或玻璃殼體之內,以與外部引線及多個電極(或接點)接合。刺激裝置可以是任何形狀,例如長方形、圓柱形,或這些與其他形狀之組合,用以被一體整合在一引線組件之內且與期望的解剖目標介入部位相容。 The stimulation device may be part of an implant medical device (IMD) architecture for a neuromodulation system, where an integrated circuit is located in a housing at a proximal end, and multiple electrodes (or body tissues are connected Point) is located at the distal end, and is configured as a cuff or other shape according to the target intervention point in the body, or is contained on a lead. Compared to conventional implanted medical devices, stimulation devices can be relatively small, and in some examples, the cross-sectional dimensions are the same or similar to the cross-sectional dimensions of a lead. A stimulation device can be hermetically incorporated in a biocompatible ceramic or glass housing with multiple electrical feedthroughs to interface with external leads and multiple electrodes (or contacts). The stimulation device may be of any shape, such as rectangular, cylindrical, or a combination of these and other shapes, to be integrated into a lead assembly and compatible with the desired anatomical target intervention site.

在某些例子中,刺激裝置可以以無線方式通訊地耦接至引線上之多個電極。舉例而言,刺激裝置可產生一刺激信號(例如,在20kHz至50kHz之範圍內的一交流電信號),且此些電極可以是一個或多個線圈之型式,其中線圈係磁性地及無線地耦接至刺激裝置之一內部線圈,以形成一共振網路。舉例而言,因為一線圈具有兩端,所以電極之數目可為兩個,用以刺激或阻斷在身體組織中傳播之生理信號。在這些例子中可能不需要一饋通介面,其可改善可植入裝置之可靠度。 In some examples, the stimulation device may be communicatively coupled to a plurality of electrodes on a lead. For example, the stimulation device may generate a stimulation signal (for example, an alternating current signal in a range of 20 kHz to 50 kHz), and these electrodes may be in the form of one or more coils, where the coils are magnetically and wirelessly It is coupled to an internal coil of a stimulation device to form a resonance network. For example, since a coil has two ends, the number of electrodes can be two to stimulate or block physiological signals transmitted in body tissues. In these examples, a feedthrough interface may not be needed, which can improve the reliability of the implantable device.

依據某些例子,一刺激裝置可包含一積體電路,例如至少一特定用途積體電路(Application-Specific Integrated Circuit,ASIC),且可包含一電池。積體電路可執行各種功能。這些功能之例子包含傳送電脈衝並紀錄來自與身體組織形成一神經介面之電極之資料、使用一內部線圈接收來自一磁化感應場之電力、調節電源電壓、幫電池充電與監視其充電狀態以及與一輔助裝置建立一雙向遙測鏈路以交換命令功能並傳輸資料。刺激裝置亦可包含一用於電力及資料遙測之線圈。在某些例子中,電池在缺乏一磁化場的情況下提供電力。 According to some examples, a stimulation device may include an integrated circuit, such as at least one Application-Specific Integrated Circuit (ASIC), and may include a battery. Integrated circuits perform various functions. Examples of these functions include transmitting electrical pulses and recording data from electrodes that form a neural interface with body tissue, using an internal coil to receive power from a magnetized induction field, adjusting the power supply voltage, helping the battery charge and monitor its charging status, and An auxiliary device establishes a two-way telemetry link to exchange command functions and transmit data. The stimulation device may also include a coil for power and data telemetry. In some examples, batteries provide power in the absence of a magnetizing field.

在刺激裝置之內的線圈,可經由感應而無線地耦接至一外部磁化線圈,以使刺激裝置通電並提供電力以幫電池充電。或者,從磁化場 中提取的電力可被使用以直接地給患者提供治療,而不需要幫電池充電。在缺乏足夠磁化場的情況下,電池可提供電力給植入裝置以提供治療。 The coil inside the stimulation device can be wirelessly coupled to an external magnetized coil via induction to energize the stimulation device and provide power to charge the battery. Alternatively, the power drawn from the magnetized field can be used to provide treatment directly to the patient without the need to charge the battery. In the absence of a sufficient magnetization field, the battery can provide power to the implanted device to provide treatment.

電池可以是比在植入醫療裝置中另外使用的尺寸來得更小。因此,可以由電池儲存並提供之能量的量可以比正常使用的來得小。再者,因為典型的可充電電池只可以循環一有限的次數(譬如500至2000次循環),所以在電池壽命期間的總可用能量可能不足以在植入裝置之期望壽命期間提供治療。在刺激裝置缺乏一電池的情況下或在刺激裝置中之電池之壽命之後,輔助裝置可經由感應以無線方式提供額外電力給刺激裝置。 The battery may be smaller than the size otherwise used in implanted medical devices. Therefore, the amount of energy that can be stored and provided by the battery can be smaller than that used normally. Furthermore, because a typical rechargeable battery can only be cycled a limited number of times (eg, 500 to 2000 cycles), the total available energy during the battery life may not be sufficient to provide treatment during the expected life of the implanted device. In the event that the stimulation device lacks a battery or after the life of the battery in the stimulation device, the auxiliary device may wirelessly provide additional power to the stimulation device via induction.

刺激裝置可以無線地耦接至輔助裝置,以順應超過治療上的能階之寬廣範圍的患者治療需求,而不需要改變在刺激裝置之內的部件。在一個例子中,包含刺激裝置主體及一引線之引線組件之近端,可被插入至一固定至輔助裝置之連接器或頭部。輔助裝置之頭部可以由例如環氧樹脂(epoxy)的絕緣材料製成,並且可以是用於容納引線組件之近端的一機械儲存容器。不像涉及電性接點和矽膠隔離環以容納各個引線端子之巴賽爾連接器(bal-seal connectors),可能不需要多個接點以建立一條在引線組件與儲存容器之間的直流電路徑。藉由消除對於在引線組件與輔助裝置之間的多個電氣接點之需求,可大幅地減小頭部及儲存容器之尺寸。 The stimulation device can be wirelessly coupled to the auxiliary device to comply with a wide range of patient treatment needs beyond the therapeutic energy level without changing the components within the stimulation device. In one example, the proximal end of a lead assembly including a stimulation device body and a lead may be inserted into a connector or head secured to an auxiliary device. The head of the auxiliary device may be made of an insulating material such as epoxy, and may be a mechanical storage container for receiving the proximal end of the lead assembly. Unlike bal-seal connectors that involve electrical contacts and silicone isolation rings to accommodate each lead terminal, multiple contacts may not be required to establish a DC path between the lead assembly and the storage container . By eliminating the need for multiple electrical contacts between the lead assembly and the auxiliary device, the size of the head and the storage container can be greatly reduced.

刺激裝置與輔助裝置可藉由一近場鄰近式鏈路而被無線地耦接。當刺激裝置與輔助裝置彼此接近時,藉由譬如將刺激裝置(或刺激裝置之一部分)插入至輔助裝置頭部之儲存容器,刺激裝置與輔助裝置可藉由建立一條允許在此些裝置之間的雙向資料傳輸的無線通道進行配對,且刺激裝置之供電應是在刺激裝置需要充電時之一電池。在某些例子中,一個 以上的刺激裝置可以體內無線地耦接至一輔助裝置,且每個刺激裝置可藉由使用獨特的數字識別編號和及資料協定而被獨立定址。 The stimulation device and the auxiliary device can be wirelessly coupled through a near-field proximity link. When the stimulating device and the assisting device are close to each other, for example, by inserting the stimulating device (or a part of the stimulating device) into a storage container on the head of the assisting device, the stimulating device and the assisting device can be established by allowing a space between the devices. The two-way data transmission wireless channel is paired, and the power of the stimulation device should be one of the batteries when the stimulation device needs to be charged. In some examples, more than one stimulation device may be wirelessly coupled to an auxiliary device in the body, and each stimulation device may be independently addressed by using a unique numeric identification number and data protocol.

依據某些例子之一輔助裝置可包含一無線電收發器及一天線,用以與一體外患者遠端裝置或臨床醫生遠端裝置通信。輔助裝置亦可包含一處理器及一記憶體次系統,用以處理及儲存資料,管理輔助裝置之整體運作,以及管理與外部充電器及與刺激裝置的連通。可包含一個或多個積體電路,以管理在輔助裝置與刺激裝置之間的無線供電,電池管理與鄰接式鏈路。輔助裝置亦可包含一可充電電池以提供電力給植入裝置。在另一個例子中,輔助裝置除了刺激裝置以外,尚可包含多個刺激及資料紀錄電路及多條電饋通,以接合最接近身體組織之額外電極。 According to some examples, an auxiliary device may include a radio transceiver and an antenna for communicating with an external patient remote device or a clinician remote device. The auxiliary device may also include a processor and a memory subsystem to process and store data, manage the overall operation of the auxiliary device, and manage communication with external chargers and stimulation devices. It may contain one or more integrated circuits to manage wireless power supply between the auxiliary device and the stimulation device, battery management and adjacency link. The auxiliary device may also include a rechargeable battery to provide power to the implanted device. In another example, in addition to the stimulation device, the auxiliary device may include multiple stimulation and data recording circuits and multiple electrical feedthroughs to engage additional electrodes closest to the body tissue.

在輔助裝置與刺激裝置之間的鄰近鏈路可利用一些方法來實施。這些方法之例子包含將例如一E類驅動器或一D類放大器之一高效率發送器結合在輔助裝置之內,用以磁化一種可以無線地耦接至刺激裝置內的一接收線圈的傳輸線圈。遙測資料可藉由譬如將資訊編碼在傳輸載體頻率(transmit carrier frequency)之振幅或相位中而被傳輸至刺激裝置。類似地,從刺激裝置至輔助裝置之遙測資料可藉由使用負載轉變鍵控(load shift keying)或其他方法,來調變反映阻抗而被傳輸。 The proximity link between the assistive device and the stimulation device can be implemented using some methods. Examples of these methods include incorporating a high-efficiency transmitter such as a Class E driver or a Class D amplifier in an auxiliary device to magnetize a transmission coil that can be wirelessly coupled to a receiving coil in a stimulation device. The telemetry data may be transmitted to the stimulation device by, for example, encoding information in the amplitude or phase of a transmit carrier frequency. Similarly, telemetry data from the stimulation device to the auxiliary device can be transmitted by using load shift keying or other methods to modulate the reflected impedance.

在輔助裝置與刺激裝置之間的鄰近鏈路可允許由輔助裝置所提供之電力,用以為刺激裝置供電並為刺激裝置的電池再充電。此電力可被提供給輔助裝置之傳輸電感器線圈以產生一交流電,用以磁化傳輸電感器,且藉以產生多條耦接至刺激裝置中之接收線圈之磁通量線。由磁化場所感應生成的電壓可利用一種方式進行整流及調整,用以確保刺激裝置 之適當運作,包含使用定電流及定電壓充電波形幫電池充電。 The proximity link between the assistive device and the stimulation device may allow power provided by the assistive device to power the stimulation device and recharge the battery of the stimulation device. This power can be provided to the transmission inductor coil of the auxiliary device to generate an alternating current to magnetize the transmission inductor, thereby generating a plurality of magnetic flux lines coupled to the reception coil in the stimulation device. The voltage induced by the magnetized field can be rectified and adjusted in a way to ensure the proper operation of the stimulation device, including charging the battery with a constant current and a constant voltage charging waveform.

在另一個例子中,傳輸電感器線圈可被定位在輔助裝置之頭部內部,以增加在傳輸線圈與接收線圈之間的耦合強度,並改善在輔助裝置與刺激裝置之間的整體電路鏈路效率。一個單一輔助裝置可藉由使輔助裝置之單一或多個傳輸線圈,來包圍一跨越多個刺激裝置的接收線圈的尺寸的區域,而被無線地耦接至多個刺激裝置。舉例而言,一傳輸線圈可被併入在一可容納刺激裝置之頭部儲存容器的內部。 In another example, the transmission inductor coil may be positioned inside the head of the auxiliary device to increase the coupling strength between the transmission coil and the receiving coil and improve the overall circuit link between the auxiliary device and the stimulation device. effectiveness. A single auxiliary device can be wirelessly coupled to multiple stimulation devices by having a single or multiple transmission coils of the auxiliary device surround an area the size of a receiving coil spanning multiple stimulation devices. For example, a transmission coil may be incorporated inside a head storage container that can accommodate a stimulation device.

在另一個例子中,輔助裝置中之一單一線圈可被使用來將電力傳輸至刺激裝置,以及從作為體外裝置的一外部充電器接收電力。在一類似的配置中,輔助裝置之線圈可以被製造成與刺激裝置強烈共振,以增加一外部充電器與此些植入裝置之間的電力鏈路的整體效率。這種強烈耦接的共振效應可被使用來改善在外部充電器與輔助裝置之間,或在外部充電器與刺激裝置之間的無線充電效率,從而致能從一體外電源直接給刺激裝置充電。 In another example, a single coil in an auxiliary device can be used to transmit power to the stimulation device and to receive power from an external charger as an extracorporeal device. In a similar configuration, the coils of the auxiliary device can be manufactured to strongly resonate with the stimulation device to increase the overall efficiency of the power link between an external charger and these implanted devices. This strongly coupled resonance effect can be used to improve the efficiency of wireless charging between an external charger and an auxiliary device, or between an external charger and a stimulation device, thereby enabling the stimulation device to be charged directly from an external power source .

在某些例子中,刺激裝置可被耦接至成一體的壓脈帶。壓脈帶可直接被耦接至一動脈、靜脈或神經,譬如一周圍神經之上,而不需要一條在刺激裝置與壓脈帶之間的引線。電力可以由一刺激裝置電池提供,或直接由耦接至刺激裝置線圈的一外部激勵場(energizing field)提供。 In some examples, the stimulation device may be coupled to an integrated pressure band. The compression band can be directly coupled to an artery, vein or nerve, such as a peripheral nerve, without the need for a lead between the stimulation device and the compression band. Power can be provided by a stimulation device battery or directly by an external energizing field coupled to the coil of the stimulation device.

使用本揭露內容之各種例子可以使一可植入系統適應不同的目標介入部位,神經/電極介面以及治療上的能量輸送需求以供刺激及中斷用。舉例而言,具有成一體的壓脈帶之一體成型機身(unibody)的刺激裝置,可允許刺激裝置直接地耦接至一動脈、靜脈或神經,譬如周圍神經, 於此在治療期間由植入物提供的能量通常被認為是低的。當多條引線用於從一非常小的神經介面轉變到稍大的引線組件時,相同的刺激裝置可另外被併入一短引線組件之內。相同的刺激裝置可藉由使用無線耦合技術而無接縫地與一輔助裝置組成一對,而不需要改變引線配置。當治療上的能量需求超過可以由一在刺激裝置之內的電源提供之能量之數量時,可使用此種配置。在某些例子中,可使用具有較大的能量源之植入裝置(例如在輔助裝置中),以確保治療是在不需要依據患者依從性的情況下被進行。 Using the various examples of this disclosure, an implantable system can be adapted to different target intervention sites, nerve / electrode interfaces, and therapeutic energy delivery needs for stimulation and interruption. For example, a stimulating device with a unibody that is an integrated pressure venous band may allow the stimulating device to be directly coupled to an artery, vein, or nerve, such as a peripheral nerve. The energy provided by the feed is generally considered low. When multiple leads are used to transition from a very small neural interface to a slightly larger lead assembly, the same stimulation device may be additionally incorporated into a short lead assembly. The same stimulation device can be paired with an auxiliary device seamlessly by using wireless coupling technology without changing the lead arrangement. This configuration may be used when the therapeutic energy requirement exceeds the amount of energy that can be provided by a power source within the stimulation device. In some examples, implanted devices with larger energy sources (eg, in assistive devices) can be used to ensure that treatment is performed without the need for patient compliance.

以下討論某些例子之詳細說明。提供這些說明性例子是為了向讀者介紹這裡討論的一般主題,且並非意圖限制所揭露的概念之範疇。下述段落參考圖式說明各種額外實施樣態及例子,於此些圖式中,相同的數字表示相同的元件,且方向性描述係用於描述說明性例子,但是與說明性例子一樣,不應用於限制本揭露內容。以下所說明之各種圖描繪了關於本揭露內容之實施例之例子,但不應用於限制本揭露內容。 A detailed description of some examples is discussed below. These illustrative examples are provided to introduce the reader to the general topics discussed here, and are not intended to limit the scope of the concepts disclosed. The following paragraphs describe various additional implementation modes and examples with reference to the drawings. In these drawings, the same numbers represent the same elements, and the directional description is used to describe the illustrative examples, but is the same as the illustrative examples. Used to limit this disclosure. The various figures described below depict examples of embodiments of the disclosure, but should not be used to limit the disclosure.

圖1為依據一個例子之一種具有可無線地耦接體內之多個部件之系統10之方塊圖。系統10包含一輔助裝置12及一耦接至一具有多個電極16的一引線之刺激裝置14。輔助裝置12與刺激裝置14兩者係被定位在身體組織20之體內側18上,於此刺激裝置14之此些電極可被定位,以與內部身體組織20進行物理接觸。此系統亦包含一體外裝置22,其被定位在身體組織20之體外側24上。體外裝置22可分別經由線圈26及28而無線地耦接至輔助裝置12。 FIG. 1 is a block diagram of a system 10 having a plurality of components in a body that can be wirelessly coupled according to an example. The system 10 includes an auxiliary device 12 and a stimulation device 14 coupled to a lead having a plurality of electrodes 16. Both the auxiliary device 12 and the stimulation device 14 are positioned on the inner side 18 of the body tissue 20, where the electrodes of the stimulation device 14 can be positioned to make physical contact with the internal body tissue 20. This system also includes an extracorporeal device 22 that is positioned on the outer side 24 of the body tissue 20. The extracorporeal device 22 may be wirelessly coupled to the auxiliary device 12 via the coils 26 and 28, respectively.

輔助裝置12可包含一個或多個線圈28,用以無線地耦合至體外裝置22及刺激裝置14。舉例而言,輔助裝置12可藉由無線地耦合至體內 刺激裝置14來提供電力及命令給包含多個線圈30之刺激裝置14。刺激裝置14可刺激或阻斷身體組織20,從電極收集關於身體組織之資訊,或執行其他功能。輔助裝置12與體外裝置22可分別包含天線32及34,用以經由多個射頻信號連接資訊及命令,以補充或替代無線感應耦合鏈路。 The assistive device 12 may include one or more coils 28 for wirelessly coupling to the extracorporeal device 22 and the stimulation device 14. For example, the auxiliary device 12 may provide power and commands to the stimulation device 14 including a plurality of coils 30 by being wirelessly coupled to the in-vivo stimulation device 14. The stimulation device 14 may stimulate or block the body tissue 20, collect information about the body tissue from the electrodes, or perform other functions. The auxiliary device 12 and the extracorporeal device 22 may include antennas 32 and 34, respectively, for connecting information and commands through multiple radio frequency signals to supplement or replace the wireless inductive coupling link.

在其他例子中,刺激裝置14雖然亦能夠經由無線耦合與輔助裝置12連接,但可直接無線地耦接至體外裝置22,且輔助裝置12可能不存在。在某些例子中,刺激裝置14包含一無線電收發器及一天線(未顯示),用以補充或替代經由電感耦合與體外裝置22連接而與體外裝置22相通。此外,刺激裝置14與輔助裝置12兩者的存在,每個擁有具有一共振頻率的線圈28及30,可以給與體外裝置22的無線耦合帶來一擴大效應,並改善與體外裝置22的電力及通訊傳輸。 In other examples, although the stimulation device 14 can also be connected to the auxiliary device 12 via wireless coupling, it can be directly and wirelessly coupled to the extracorporeal device 22, and the auxiliary device 12 may not exist. In some examples, the stimulation device 14 includes a radio transceiver and an antenna (not shown) to supplement or replace the external device 22 connected to the external device 22 via inductive coupling. In addition, the presence of both the stimulation device 14 and the auxiliary device 12, each having coils 28 and 30 having a resonance frequency, can bring an expansion effect to the wireless coupling with the external device 22 and improve the power with the external device 22 And communication transmission.

圖2為依據一個例子之一可植入系統之一輔助裝置100及一刺激裝置102之方塊圖。輔助裝置100包含一與一天線108連通之無線電收發器106、一處理器及一記憶體110,以及一用以無線地輸出高電壓電力之線圈驅動器112。線圈驅動器112係耦接至一電源及一個或多個線圈116,電源為一電池114,而線圈116用以與一體外裝置(顯示於圖1)與刺激裝置102無線地耦合。圖2顯示兩個線圈116,但是可以使用任何數量的線圈,包含一個。 FIG. 2 is a block diagram of an auxiliary device 100 and a stimulation device 102 of an implantable system according to an example. The auxiliary device 100 includes a radio transceiver 106 in communication with an antenna 108, a processor and a memory 110, and a coil driver 112 for wirelessly outputting high-voltage power. The coil driver 112 is coupled to a power source and one or more coils 116. The power source is a battery 114, and the coil 116 is used to wirelessly couple an external device (shown in FIG. 1) and the stimulation device 102. Figure 2 shows two coils 116, but any number of coils may be used, including one.

處理器可執行儲存於記憶體之指令,用於執行輔助裝置之某些操作。處理器可包含一單一處理裝置或多重處理裝置。處理器之例子包含一現場可程式化閘陣列、一特定用途積體電路(“ASIC”),及一微處理器。記憶體之至少一部分可包含一非暫時性電腦-可讀取媒體,處理器可從其中存取及執行記憶體之指令。電腦-可讀取媒體可包含能夠提供處理器電腦- 可讀取指令或其他程式碼之電氣、光學、磁性或其他儲存裝置。電腦-可讀取媒體之例子包含快閃記憶體、記憶體晶片、唯讀記憶體,隨機存取記憶體(例如鐵電隨機存取記憶體或相變記憶體)、一特定用途積體電路、一配置處理器,及光學儲存。此些指令可包含多個由一編譯器或一解譯器從以任何適當的電腦程式語言寫入的代碼所生成的處理器特定的指令,電腦程式語言包含譬如C、C++、C#、組合程式語言等。 The processor can execute instructions stored in the memory for performing certain operations on the auxiliary device. The processor may include a single processing device or multiple processing devices. Examples of processors include a field programmable gate array, a special purpose integrated circuit ("ASIC"), and a microprocessor. At least a portion of the memory may include a non-transitory computer-readable medium from which a processor may access and execute instructions of the memory. Computer-readable media may include electrical, optical, magnetic or other storage devices capable of providing a processor computer-readable instructions or other code. Examples of computer-readable media include flash memory, memory chips, read-only memory, random access memory (such as ferroelectric random access memory or phase change memory), and a special-purpose integrated circuit , A configuration processor, and optical storage. Such instructions may include multiple processor-specific instructions generated by a compiler or an interpreter from code written in any suitable computer programming language, such as C, C ++, C #, a combination program Language, etc.

此些指令包含一個或多個應用或其他引擎,用於指示處理器執行各種功能。這些功能之例子包含接收多個從由無線電收發器106所接收之多個信號之命令,輸出多個命令至刺激裝置102以刺激或阻斷身體組織,儲存從刺激裝置102接收的資料,以及控制電力傳輸至刺激裝置。 These instructions contain one or more applications or other engines that instruct the processor to perform various functions. Examples of these functions include receiving multiple commands from multiple signals received by the radio transceiver 106, outputting multiple commands to the stimulation device 102 to stimulate or block body tissue, storing data received from the stimulation device 102, and controlling Power is transmitted to the stimulation device.

刺激裝置102包含一積體電路118、一個或多個線圈120及一電極介面122。圖2顯示供刺激裝置102用之一個線圈120,但可使用任何數量的線圈。線圈120可經由一鄰近鏈路(proximity link)124無線地耦接至輔助裝置100之一線圈116以接收電力或交換資料。電極介面122可允許刺激裝置102通訊地耦接至供身體組織用之多個電極,用以輸出多個刺激或中斷電氣信號並接收來自此些電極之資料。 The stimulation device 102 includes an integrated circuit 118, one or more coils 120, and an electrode interface 122. FIG. 2 shows one coil 120 for the stimulation device 102, but any number of coils may be used. The coil 120 may be wirelessly coupled to a coil 116 of the auxiliary device 100 via a proximity link 124 to receive power or exchange data. The electrode interface 122 may allow the stimulation device 102 to be communicatively coupled to a plurality of electrodes for body tissue, to output a plurality of stimuli or interrupt electrical signals and to receive data from these electrodes.

積體電路118可執行各種功能,例如提供高電壓刺激,資料紀錄及管理無線耦合、電力及資料傳輸,以及電池充電。包含在刺激裝置中的是一電源126(於本實施例中是一電池),其可以藉由從輔助裝置100無線傳輸的電力來充電。刺激裝置102中之電池126可以小於輔助裝置100之電池114。在其他例子中,刺激裝置並不包含一電池,反而是藉由輔助裝置或一體外裝置經由無線耦合供電。 The integrated circuit 118 can perform various functions, such as providing high voltage stimulation, data recording and management wireless coupling, power and data transmission, and battery charging. Included in the stimulation device is a power source 126 (a battery in this embodiment), which can be charged by the power wirelessly transmitted from the auxiliary device 100. The battery 126 in the stimulation device 102 may be smaller than the battery 114 of the auxiliary device 100. In other examples, the stimulation device does not include a battery, but instead is powered by an assistive device or an external device via wireless coupling.

圖3為依據另一個例子之一輔助裝置200之方塊圖。除了射頻收發器202及天線204、處理器及記憶體206、一個或多個線圈208以及電源210以外,輔助裝置200包含一積體電路212,其為一線圈接收器/驅動器及一電極介面。電極介面可允許輔助裝置通訊地耦接至供身體組織用之多個電極214。積體電路212可控制多個提供給此些電極214之電氣信號並接收來自此些電極214之資料。除了一刺激裝置以外,可使用輔助裝置200以提供一數目更多的電極供身體組織用。 FIG. 3 is a block diagram of an auxiliary device 200 according to another example. In addition to the RF transceiver 202 and antenna 204, the processor and memory 206, one or more coils 208, and the power supply 210, the auxiliary device 200 includes an integrated circuit 212, which is a coil receiver / driver and an electrode interface. The electrode interface may allow the auxiliary device to be communicatively coupled to a plurality of electrodes 214 for use in body tissue. The integrated circuit 212 can control a plurality of electrical signals provided to the electrodes 214 and receive data from the electrodes 214. In addition to a stimulating device, an auxiliary device 200 may be used to provide a larger number of electrodes for body tissue.

圖4A及4B顯示依據某些例子之一刺激裝置300。圖4A為刺激裝置300之透視圖。圖4B為刺激裝置300之前視圖。圖4A及4B中之刺激裝置300為高度大於寬度之長方形的形狀。連同厚度,可為一特定應用及性能選擇高度及寬度。然而,依據其他例子之一刺激裝置可以不同地被塑形,例如被塑形為圓柱形。 4A and 4B show a stimulation device 300 according to one of some examples. FIG. 4A is a perspective view of the stimulation device 300. FIG. FIG. 4B is a front view of the stimulation device 300. The stimulation device 300 in FIGS. 4A and 4B has a rectangular shape having a height greater than a width. Together with thickness, height and width can be selected for a specific application and performance. However, according to one of the other examples, the stimulation device may be shaped differently, for example, shaped into a cylindrical shape.

刺激裝置300具有一外殼302,於此例子中為透明玻璃。另一種型式之外殼之一例子為一陶瓷外殼。在外殼之內為一線圈304、一電源306及一積體電路308,電源306為一電池,而積體電路308為一特定用途積體電路。線圈304可包圍電池306與積體電路308。在其他例子中,刺激裝置300並不包含電池,其可使包裝更小。 The stimulation device 300 has a housing 302, which in this example is transparent glass. An example of another type of casing is a ceramic casing. Inside the housing is a coil 304, a power source 306, and an integrated circuit 308. The power source 306 is a battery, and the integrated circuit 308 is a special-purpose integrated circuit. The coil 304 may surround the battery 306 and the integrated circuit 308. In other examples, the stimulation device 300 does not include a battery, which can make the package smaller.

刺激裝置300亦具有一接觸介面,其包含一個或多個饋通310,如圖4B所示。一饋通310可以是一導電接點,其可耦接至一配線或用以將積體電路通訊地耦合至一個或多個電極以供身體組織用的其他介質。饋通310可延伸通過外殼302,俾能使配線或其他介質可以耦接至饋通310。藉由分割刺激裝置300與一輔助裝置之間的功能及部件,接觸介面可以是實 體上較大的,且包含更多接點,用以通訊地耦合至更多電極供身體組織用。 The stimulation device 300 also has a contact interface, which includes one or more feedthroughs 310, as shown in FIG. 4B. A feedthrough 310 may be a conductive contact that may be coupled to a wiring or other medium used to communicatively couple the integrated circuit to one or more electrodes for use in body tissue. The feedthrough 310 can extend through the housing 302, so that wiring or other media can be coupled to the feedthrough 310. By segmenting the functions and components between the stimulation device 300 and an auxiliary device, the contact interface can be physically larger and include more contacts for communicatively coupling to more electrodes for body tissue.

圖5說明依據一個例子之經由一引線400耦接至一包含多個電極之壓脈帶402之刺激裝置300之一例。引線400可包含一管、圓柱或其他支撐結構,在其周圍纏繞一條或多條配線以將刺激裝置通訊地耦接至包含在壓脈帶400中之電極。壓脈帶400之尺寸可被製造成用以被置放於最接近身體組織,例如最接近一動脈、靜脈或神經,譬如身體中之一周圍神經。壓脈帶400可將電極定位在最接近待被治療或監視之身體組織。此些配線可提供雙向信號傳輸,俾能使電氣信號可被提供給此些電極,且使來自電極之資料可被提供給刺激裝置300。 FIG. 5 illustrates an example of an stimulation device 300 coupled to a pressure pulse band 402 including a plurality of electrodes via a lead 400 according to an example. The lead 400 may include a tube, a cylinder, or other support structure, and one or more wires are wound around it to communicatively couple the stimulation device to an electrode included in the pressure pulse band 400. The cuff 400 can be sized to be placed closest to a body tissue, such as an artery, vein or nerve, such as a peripheral nerve in the body. Compression strap 400 may position the electrode closest to the body tissue to be treated or monitored. These wirings can provide bidirectional signal transmission, so that electrical signals can be provided to the electrodes, and data from the electrodes can be provided to the stimulation device 300.

圖5中之刺激裝置300可被定位於相對於一輔助裝置之一段距離(顯示於圖6),以使刺激裝置300經由線圈無線地耦接至一輔助裝置。刺激裝置300與輔助裝置可能是實體上分開的或刺激裝置300可實體上接觸輔助裝置,但經由無線耦合來通信。 The stimulation device 300 in FIG. 5 may be positioned at a distance relative to an auxiliary device (shown in FIG. 6), so that the stimulation device 300 is wirelessly coupled to an auxiliary device via a coil. The stimulation device 300 and the auxiliary device may be physically separate or the stimulation device 300 may physically contact the auxiliary device, but communicate via wireless coupling.

圖6為依據一個例子之實體上容納在一輔助裝置500之一部分中之圖5之刺激裝置300之透視圖。輔助裝置500包含一頭部502,其具有被塑形以接收並維持刺激裝置300之一埠。頭部502可被塑形成類似於一卡匣盒(cassette case),以使刺激裝置300可經由例如來自一醫療專家或來自一工具的一故意力量,而非來自例如體內裝置一般經歷的力量之無意的力量,而受到移除。圖7為依據一個例子之來自圖6之刺激裝置300與輔助裝置500之側視圖,而沒有顯示頭部502。雖然刺激裝置與輔助裝置可能呈現實體接觸,但裝置之間的通訊可以是經由一在刺激裝置300之線圈600與輔助裝置500之線圈602之間的無線耦合,如以圖7中之雙箭頭所顯示者。 FIG. 6 is a perspective view of the stimulation device 300 of FIG. 5 physically contained in a portion of an auxiliary device 500 according to an example. The auxiliary device 500 includes a head 502 having a port shaped to receive and maintain the stimulation device 300. The head 502 can be shaped similar to a cassette case, so that the stimulation device 300 can be driven by a deliberate force, such as from a medical professional or from a tool, rather than from forces typically experienced by, for example, an in-vivo device. Unintentional force while being removed. FIG. 7 is a side view of the stimulation device 300 and the auxiliary device 500 from FIG. 6 without showing the head 502 according to an example. Although the stimulation device and the auxiliary device may present physical contact, the communication between the devices may be via a wireless coupling between the coil 600 of the stimulation device 300 and the coil 602 of the auxiliary device 500, as indicated by the double arrow in FIG. Show by.

圖8A及8B說明依據一個例子之具有一壓脈帶702之一刺激裝置700。壓脈帶702具有一頂端部分704,其被塑形成容納刺激裝置700以形成一種「一體成型機身」設計。頂端部分702亦可被塑形成維持刺激裝置700,或可使用一附著機構以將刺激裝置700維持在頂端部分702中。刺激裝置700之一接觸介面可將刺激裝置通訊地耦接至電極,而不需要使用一引線。 8A and 8B illustrate a stimulation device 700 having a pressure band 702 according to an example. The blood pressure belt 702 has a top portion 704 that is molded to receive the stimulation device 700 to form a "one-piece body" design. The top portion 702 may also be shaped to maintain the stimulation device 700, or an attachment mechanism may be used to maintain the stimulation device 700 in the top portion 702. A contact interface of the stimulation device 700 can communicatively couple the stimulation device to the electrode without using a lead.

依據某些例子,一可植入系統可容納供一刺激裝置用之一高密度之接點以容納數目更多的電極。在某些例子中,可使用半導體技術來製作一接觸介面800以增加接點之數目及密度。圖9說明依據某些例子之供一刺激裝置用之一接觸介面800之局部切除視圖。接觸介面800包含具有多條傳導線802的一些接點801,此些傳導線802將接點耦合至配線,或將其他介質耦合至電極(未顯示)。此些接點801及傳導線802可經由一蝕刻半導體製程或與平面半導體製造相容之平版印刷製程而製作出,用以以一精確方式在一基板上建構多個接點及線路。在其他例子中,可使用雷射能量建構此些接點801及傳導線802,用以增加或移除基板上之特徵部。圖10說明經由多個焊球904將接觸介面900耦合至一引線配線902或介質,俾能使接觸介面之接點係以一種撓性方式耦接至配線之一例子之側視圖。在其他例子中,可使用一種環氧樹脂或另一種物理耦合配置以將接觸介面耦接至一個或多個引線配線。 According to some examples, an implantable system can accommodate a high density of contacts for a stimulation device to accommodate a larger number of electrodes. In some examples, a semiconductor interface may be used to fabricate a contact interface 800 to increase the number and density of contacts. FIG. 9 illustrates a partial cutaway view of a contact interface 800 for a stimulation device according to some examples. The contact interface 800 includes a plurality of contacts 801 having a plurality of conductive lines 802, which couple the contacts to wirings, or couple other media to electrodes (not shown). The contacts 801 and the conductive lines 802 can be fabricated through an etched semiconductor process or a lithographic process compatible with planar semiconductor manufacturing, and used to construct multiple contacts and circuits on a substrate in a precise manner. In other examples, the laser energy can be used to construct these contacts 801 and conductive lines 802 to add or remove features on the substrate. FIG. 10 illustrates a side view of an example in which the contact interface 900 is coupled to a lead wiring 902 or a dielectric via a plurality of solder balls 904 to enable the contacts of the contact interface to be coupled to the wiring in a flexible manner. In other examples, one epoxy or another physical coupling configuration may be used to couple the contact interface to one or more lead wiring.

使用依據某些例子之一可植入系統架構可為體內系統提供在決定一物理印跡方面的彈性。舉例而言,一刺激裝置可獨立於一輔助裝置或與一輔助裝置一起使用,耦接至一具有多個電極的引線,經由一引線 耦接至一具有多個電極之壓脈帶,直接地耦接至壓脈帶,實體上與輔助裝置分離,或實體上耦接至輔助裝置。 The use of an implantable system architecture based on some examples may provide in vivo systems with flexibility in determining a physical footprint. For example, a stimulation device can be used independently of or together with an auxiliary device, coupled to a lead with multiple electrodes, coupled to a pressure cuff with multiple electrodes via a lead, directly It is coupled to the pressure belt, physically separated from the auxiliary device, or physically coupled to the auxiliary device.

以上對本發明的實施例(包括圖示的實施例)的描述僅僅是為了說明和描述的目的而提出的,並非意圖是詳盡無遺的或將本發明限制於所公開的精確形式中。在不脫離本發明的範圍的情況下,對本領域技術人員來說,許多修改,改變和使用將是顯而易見的。給出上面描述的說明性示例以向閱讀的人介紹在此討論的一般主題,而不是要限制所公開的概念的範圍。 The foregoing descriptions of the embodiments (including the illustrated embodiments) of the present invention have been presented for the purpose of illustration and description only, and are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications, changes, and uses will be apparent to those skilled in the art without departing from the scope of the invention. The illustrative examples described above are given to introduce the reader to the general topics discussed herein, and not to limit the scope of the concepts disclosed.

Claims (17)

一種可植入系統,包含:一刺激裝置,可在體內定位並配置成通訊地耦接至多個電極,該些電極配置成刺激或阻斷身體組織;及一輔助裝置,可在體內定位並包含一個或多個線圈,配置成在體內無線地耦接至該刺激裝置及無線地耦接至一體外裝置。     An implantable system includes: a stimulation device that can be positioned in the body and configured to be communicatively coupled to a plurality of electrodes that are configured to stimulate or block body tissue; and an auxiliary device that can be positioned in the body and includes One or more coils configured to be wirelessly coupled to the stimulation device in vivo and wirelessly coupled to an external device.     如申請專利範圍第1項所述之可植入系統,其中該刺激裝置包含:一積體電路,配置成通過一介面管理到達該些電極的信號傳輸;及一個或多個刺激裝置線圈,配置成在體內無線地耦接至該輔助裝置,並配置成無線地耦接至該體外裝置。     The implantable system according to item 1 of the scope of patent application, wherein the stimulation device includes: an integrated circuit configured to manage signal transmission to the electrodes through an interface; and one or more stimulation device coils configured The device is wirelessly coupled to the auxiliary device in vivo and is configured to be wirelessly coupled to the external device.     如申請專利範圍第2項所述之可植入系統,其中該刺激裝置包含:一電源,供該積體電路用,該電源係可充電。     The implantable system according to item 2 of the scope of patent application, wherein the stimulation device comprises: a power source for the integrated circuit, and the power source is rechargeable.     如申請專利範圍第2項所述之可植入系統,其中該輔助裝置包含:一電源,可透過無線耦合由該體外裝置充電;一無線電收發器;一天線,用以提供一無線路徑給來自與無線耦合分離的該無線電收發器的多個信號使用;一處理器;及 一非暫時性電腦可讀媒體,儲存多個指令,該些指令可由該處理器執行來:接收來自被該無線電收發器所接收之多個信號之多個命令;輸出多個命令至該刺激裝置以刺激或阻斷該身體組織;儲存從該刺激裝置接收之資料;以及控制電力傳輸至該刺激裝置。     The implantable system according to item 2 of the patent application scope, wherein the auxiliary device includes: a power source that can be charged by the external device through wireless coupling; a radio transceiver; and an antenna for providing a wireless path from Use of multiple signals of the radio transceiver separated from wireless coupling; a processor; and a non-transitory computer-readable medium storing a plurality of instructions executable by the processor: Multiple commands of multiple signals received by the device; outputting multiple commands to the stimulation device to stimulate or block the body tissue; storing data received from the stimulation device; and controlling power transmission to the stimulation device.     如申請專利範圍第4項所述之可植入系統,其中該輔助裝置更包含:一輔助裝置積體電路,配置成通過一輔助裝置介面管理到達配置成刺激或阻斷該身體組織之額外電極的信號傳輸。     The implantable system according to item 4 of the scope of patent application, wherein the auxiliary device further comprises: an auxiliary device integrated circuit configured to manage through an auxiliary device interface to reach additional electrodes configured to stimulate or block the body tissue Signal transmission.     如申請專利範圍第2項所述之可植入系統,其中該刺激裝置包含到達該些電極之該介面,該介面包含一個或多個饋通,使連接至該些電極之多條配線能耦接至在該刺激裝置之一外殼中的多個刺激裝置接點,該介面係藉由使用一雷射或與平面半導體製造相容之一平版印刷製程而形成。     The implantable system according to item 2 of the scope of patent application, wherein the stimulation device includes the interface to the electrodes, the interface includes one or more feedthroughs, so that a plurality of wirings connected to the electrodes can be coupled Connected to a plurality of stimulation device contacts in a housing of the stimulation device, the interface is formed by using a laser or a lithographic process compatible with planar semiconductor manufacturing.     如申請專利範圍第1項所述之可植入系統,更包含:一壓脈帶,包含該些電極,該壓脈帶係可定位最接近體內之一動脈、靜脈或神經,其中該刺激裝置係配置成經由一引線直接地或間接地耦接至該壓脈帶。     The implantable system according to item 1 of the scope of patent application, further comprising: a pressure venous band including the electrodes, the pressure venous band can locate an artery, vein or nerve closest to the body, wherein the stimulation device It is configured to be directly or indirectly coupled to the blood pressure band via a lead.     如申請專利範圍第7項所述之可植入系統,其中該壓脈帶包含一頂端部分,塑形成容納及維持該刺激裝置。     The implantable system according to item 7 of the scope of the patent application, wherein the pressure pulse band includes a top portion, which is formed to receive and maintain the stimulation device.     如申請專利範圍第1項所述之可植入系統,其中該刺激裝置係耦接至一包含該些電極之一引線。     The implantable system according to item 1 of the patent application scope, wherein the stimulation device is coupled to a lead including the electrodes.     一種可植入裝置,包含:一積體電路,配置成通過一介面管理到達配置成刺激或阻斷身體組織之多個電極的信號傳輸;及一個或多個線圈,配置成在體內無線地耦接至定位於體內之一輔助裝置並配置成無線地耦接至一體外裝置。     An implantable device includes: an integrated circuit configured to manage signal transmission to multiple electrodes configured to stimulate or block body tissue through an interface; and one or more coils configured to be wirelessly coupled in the body Connected to an auxiliary device positioned in the body and configured to be wirelessly coupled to an extracorporeal device.     如申請專利範圍第10項所述之可植入裝置,更包含:一電源,供該積體電路用,該電源是可充電的。     The implantable device described in item 10 of the scope of patent application, further includes: a power source for the integrated circuit, the power source is rechargeable.     如申請專利範圍第10項所述之可植入裝置,更包含一饋通,配置成將連接至該些電極之一條或多條配線耦接至在該可植入裝置之一外殼中的一個或多個刺激裝置接點,該介面係藉由使用一雷射或與平面半導體製造相容之一平版印刷製程而形成。     The implantable device according to item 10 of the patent application scope further includes a feedthrough configured to couple one or more wires connected to the electrodes to one of the shells of the implantable device. Or multiple stimulation device contacts, the interface is formed by using a laser or a lithographic process compatible with planar semiconductor manufacturing.     如申請專利範圍第10項所述之可植入裝置,其中該積體電路與該一個或多個線圈係在一外殼中。     The implantable device according to item 10 of the patent application scope, wherein the integrated circuit and the one or more coils are enclosed in a casing.     如申請專利範圍第13項所述之可植入裝置,更包含:一壓脈帶,包含該些電極,該壓脈帶係可定位最接近體內之一動脈、靜脈或神經,其中該外殼係配置成直接地或間接地經由一引線耦接至該壓脈帶。     The implantable device according to item 13 of the scope of patent application, further comprising: a blood pressure band including the electrodes, the blood pressure band can locate an artery, vein or nerve closest to the body, wherein the shell is It is configured to be directly or indirectly coupled to the pressure pulse band via a lead.     如申請專利範圍第13項所述之可植入裝置,其中該外殼係耦接至一包含該些電極之一引線。     The implantable device according to item 13 of the application, wherein the casing is coupled to a lead including the electrodes.     如申請專利範圍第10項所述之可植入裝置,其中該輔助裝置係配置成無線地耦接該體外裝置,該輔助裝置包含:一處理器;及一非暫時性電腦可讀媒體,於其上儲存多個指令,該些指令可由該處理器執行來:輸出多個命令至該可植入裝置以刺激或阻斷該身體組織;儲存從該可植入裝置接收之資料;及控制電力傳輸至該可植入裝置。     The implantable device according to item 10 of the patent application scope, wherein the auxiliary device is configured to wirelessly couple the extracorporeal device, the auxiliary device includes: a processor; and a non-transitory computer-readable medium, in A plurality of instructions are stored thereon, which are executable by the processor: outputting a plurality of commands to the implantable device to stimulate or block the body tissue; storing data received from the implantable device; and controlling power To the implantable device.     一種可植入系統,包含:一刺激裝置,可在體內定位並配置成用於執行該可植入系統之兩個子集之功能之一第一子集以監視、刺激或阻斷身體組織;及一輔助裝置,可在體內定位並配置成用於執行該可植入系統之該兩個子集之功能之一第二子集以監視、刺激、阻斷該身體組織,該輔助裝置包含一個或多個線圈,配置成在體內無線地耦接至該刺激裝置並配置成無線地耦接一體外裝置。     An implantable system comprising: a stimulation device that can be positioned in the body and configured to perform a first subset of the functions of two subsets of the implantable system to monitor, stimulate or block body tissue; And an auxiliary device that can be positioned and configured in the body to perform a second subset of the functions of the two subsets of the implantable system to monitor, stimulate, and block the body tissue, the auxiliary device includes a Or a plurality of coils configured to be wirelessly coupled to the stimulation device in vivo and configured to be wirelessly coupled to an external device.    
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